Single-Dose Fasting and Fed Pilot BE Study in Healthy Males and Females Not of Childbearing Potential
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
The rationale for this study is to evaluate and understand the variability of a generic alternative of abacavir, dolutegravir and lamivudine dispersible tablets for PEPFAR submission to aide in the development of pivotal studies.
详细描述
This study is to investigate the bioequivalence of Mylan's abacavir, dolutegravir and lamivudine dispersible tablets, 60 mg/5 mg/30 mg to ViiV's Triumeq Dispersible Tablets (5 mg GSK1349572 [dolutegravir]/ 60 mg abacavir/ 30 mg lamivudine) following administration of a single, oral 60 mg/5 mg/30 mg (1 x 60 mg/5 mg/30 mg) dose of Mylan's abacavir, dolutegravir and lamivudine dispersible tablets or ViiV's Triumeq Dispersible Tablets administered under fasting and fed conditions.
Adverse events will be monitored to ensure the safety and well-being of the healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject candidates must fulfill all of the following inclusion criteria to be eligible for participation in the study, unless otherwise specified:
- •18 to 55 years old.
- •Males and/or females not of child-bearing potential.
- •Each subject is required to weigh at least 50 kg (110 lbs) for men and 48 kg (106 lbs) for women and have a Body Mass Index (BMI) value less than or equal to 30.0 kg/m2 but greater than or equal to 19.0 kg/m
- •Adequate venous access in both arms.
- •Only non-tobacco/non-nicotine subjects.
- •Able to understand and sign the written Informed Consent Form.
- •Willing to follow the protocol requirements and comply with protocol restrictions.
- •All subjects should be judged by the Principal Investigator or Medical Sub- Investigator as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication.
排除标准
- •Subject candidates must not be enrolled in the study if subject meet any of the following criteria:
- •Institutionalized subjects.
- •Social Habits, Medications and Diseases will be evaluated.
- •Use of certain foods and processed candies, gums food/drinks that contain sugar alcohols.
- •Liver function tests (ALT, AST and total bilirubin).
- •Subjects who are positive for the HLA-B*5701 allele.
- •Subjects having Modified Patient Health Questionnaire (PHQ)-12 questionnaire score >
- •Subject has a creatinine clearance < 90 mL/min, as determined by the Cockroft-Gault equation.
- •Any reason which, in the opinion of the Principal Investigator or Medical Sub- Investigator, would prevent the subject from safely participating in the study.
- •Intolerance to venipuncture.
- •Donation or loss of blood or plasma.
- •Subjects who have received an investigational drug within 30 days prior to the initial dose of study medication.
- •Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the subject's participation in this study.
- •Allergy or hypersensitivity to abacavir, dolutegravir, lamivudine, other related products, or any inactive ingredients.
研究组 & 干预措施
Group 1
single-dose pharmacokinetics will be characterized in twenty-four (24) healthy, adult males and females not of childbearing potential under fasting conditions.
干预措施: abacavir, dolutegravir and lamivudine dispersible tablets (Combination Product)
Group 1
single-dose pharmacokinetics will be characterized in twenty-four (24) healthy, adult males and females not of childbearing potential under fasting conditions.
干预措施: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine (Combination Product)
Group 2
single-dose pharmacokinetics will be characterized in twenty-four (24) healthy, adult males and females not of childbearing potential under fed conditions.
干预措施: abacavir, dolutegravir and lamivudine dispersible tablets (Combination Product)
Group 2
single-dose pharmacokinetics will be characterized in twenty-four (24) healthy, adult males and females not of childbearing potential under fed conditions.
干预措施: Triumeq Dispersible Tablets 5 mg GSK1349572 [Dolutegravir]/ 60 mg Abacavir/ 30 mg Lamivudine (Combination Product)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 2 weeks
Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC) 0-t
时间窗: 2 weeks
Plasma concentration-time curve from zero to the time of the last measurable time point t
Area under the plasma concentration versus time curve (AUC)0-∞
时间窗: 2 weeks
Area under the plasma concentration-time curve from zero to infinity
次要结局
未报告次要终点